Mindray DS USA, Inc. d.b.a. Mindray North America: Medical Device Recall in 2013 - (Recall #: Z-0630-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

Product Classification:

Class II

Date Initiated: May 12, 2011

Date Posted: January 9, 2013

Recall Number: Z-0630-2013

Event ID: 63616

Reason for Recall:

There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.

Status: Terminated

Product Quantity: two units

Code Information:

510 K K080192 P/N 300BF-PA200002

Distribution Pattern:

Nationwide Distribution including OH and GA

Voluntary or Mandated:

Voluntary: Firm initiated